Engr 2, Product Development /R&D Engineer

KAYGEN•Franklin Lakes, NJ

About The Position

The R&D Project Engineer serves as the technical lead for evaluating proposed design changes to released medication delivery and vascular care products within the MDVC Sustaining Engineering program. The role takes cost-improvement ideas through feasibility and appraisal, generating technical evidence, risk assessments, and business cases to support leadership decisions about whether projects should proceed to execution. The work supports high-volume products such as syringes, needles, and flush products, while protecting product quality and assessing potential material, component, packaging, and supplier changes. The engineer plans and performs feasibility testing, evaluates impacts to design outputs, supports risk management and regulatory assessments, and defines preliminary verification and validation strategies. The position builds business cases, presents go/no-go recommendations, coordinates cross-functional partners and suppliers, and hands approved projects to execution teams with a defined scope, risk assessment, test strategy, resource estimate, and schedule. The role must comply with BD quality policies, design control procedures, and applicable safety requirements.

Requirements

Bachelor's degree in Mechanical, Biomedical, Plastics, Chemical, or Materials Engineering, or a closely related engineering discipline.
At least 3 years of engineering experience in medical device product development, sustaining engineering, or design change engineering in an FDA-regulated environment.
Working knowledge of design controls, including FDA 21 CFR 820 and ISO 13485, and risk management under ISO 14971, including assessment, documentation, and verification of design changes.
Hands-on experience writing and executing test protocols, developing test methods, and analyzing data with statistical tools such as Minitab or JMP.
Strong engineering fundamentals for plastic and elastomeric components, assemblies, and packaging.
Ability to write clear, technically rigorous protocols and reports.
Ability to manage several projects in parallel, lead through influence, and make sound recommendations with incomplete information.
Clear, concise written and verbal communication skills, including the ability to present to technical and leadership audiences.

Nice To Haves

Experience with high-volume, single-use medical devices such as syringes, needles, catheters, or prefilled flush products.
Experience evaluating material or supplier changes, including resin, elastomer, lubricant, or packaging material alternatives.
Familiarity with standards relevant to medication delivery devices, such as ISO 7886, ISO 80369, and ISO 11607.
Experience building or supporting cost-improvement business cases.
Working knowledge of injection molding, insert molding, and automated assembly sufficient to assess the manufacturability of proposed changes.
Design of experiments (DOE) experience; Six Sigma Green Belt or Design for Six Sigma training.
Experience with PLM, ERP, and document control systems such as SAP, Windchill, or Agile.
Prior experience with BD Medication Delivery Solutions products or processes.

Responsibilities

Own the technical assessment of proposed cost-improvement design changes to released products, from idea intake through feasibility and appraisal.
Define critical project assumptions and an efficient, credible analysis and testing plan to confirm or reject them.
Evaluate proposed material, component, packaging, and supplier changes against product specifications, functional performance requirements, and applicable standards.
Plan and execute feasibility testing, including sample and prototype builds, bench testing, and comparative performance testing against the current design.
Develop, troubleshoot, and execute test methods; specify fixtures and measurement equipment; perform measurement systems analysis; and analyze results using statistical methods.
Assess the impact of proposed changes on design outputs, including drawings, specifications, bills of material, labeling, and Design History File content.
Partner with Quality Affairs and Operations on risk assessments, including dFMEA, pFMEA, and risk management file updates in accordance with ISO 14971.
Define a preliminary verification and validation strategy and estimate execution-phase testing scope, cost, and duration, considering design verification, biocompatibility, sterilization, packaging, and shelf life as applicable.
Partner with Regulatory Affairs to identify regulatory implications, including whether changes may require notification or submission in key markets.
Build and validate project business cases with Finance, Procurement, and site partners, including savings basis, one-time project costs, capital needs, and savings timing.
Document appraisal results using the MDVC Project Feasibility Appraisal Review process and present go/no-go recommendations at technical reviews and platform prioritization forums.
Write concise, technically rigorous reports that distinguish known information, assumptions, and remaining risks.
Recommend stopping projects early when the technical or financial case is not viable, before significant time and expense are committed.
Coordinate input from Quality, Regulatory Affairs, Medical Affairs, Procurement, Supplier Quality, Sterilization, Packaging Engineering, and site engineering without direct authority.
Engage suppliers to obtain samples, technical data, and change information needed for evaluation.
Deliver an execution-ready project package, including scope, risk assessment, test strategy, resource estimate, and schedule, for approved projects transferring to the execution team.
Maintain accurate project status, risks, and next steps in platform tracking tools to support pipeline visibility and portfolio decisions.
Comply with BD quality policies, design control procedures, and applicable local, state, federal, and BD safety requirements.